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Maryland Board of Pharmacy
Public Board Meeting
December 21, 2016
Agenda
Date: December 21, 2016
Name Title Present Absent Present Absent
Board Committee
Ashby, D. Commissioner
Bouyoukas, E Commissioner
Gavgani, M. Z. Commissioner/President
Hardesty, J. Commissioner
Morgan, K. Commissioner
Peters, Roderick Commissioner
Robinson, T. Commissioner
Rochester, C. Commissioner/Treasurer
Roy, S. Commissioner
St. Cyr, II, Z. W. Commissioner/Secretary
Yankellow, E. Commissioner
Zagnit, B. Commissioner
Board Counsel
Bethman, L. Board Counsel
Felter, B. Staff Attorney
Board Staff
Speights-Napata, D. Executive Director
Fields, E. Deputy Director of Operations
Wu, Y. Compliance Manager
Page, A. Executive Administrative Associate
Vacant Administration and Public Support Manager
Logan, B. Legislation/Regulations Manager
Johnson, J. MIS Manager
Subject
Responsible
Party
Discussion
Action Due Date
(Assigned To)
December 21, 2016 Page 2
I. Executive
Committee
Report(s)
A.) M.
Gavgani, Board
President
B.) Z. St. Cyr,
II, Secretary
Members of the Board with a conflict of interest relating to any
item on the agenda are advised to notify the Board at this time or
when the issue is addressed in the agenda.
1. Call to Order
2. Sign-in Introduction and of meeting attendees –
(Please indicate on sign-in sheet if you are requesting CE
Units for attendance)
3. Distribution of Agenda and packet materials
4. Review and approve November 2016 Public Meeting
Minutes
II. A. Executive
Director Report
D. Speights-
Napata,
Executive
Director
1. Operations Updates
PTCB Presentation by Miriam A. Mobley-Smith
2. Meetings Update
B. Operations E. Fields,
Deputy
Director/
Operations
1. APS Unit Updates
2. Data Integrity Unit Updates
3. MIS Unit Updates
C. Licensing Y. Wu,
Compliance
Manager
1. Unit Updates
2. Monthly Statistics
License Type New Renewed Reinstated Total
Distributor 11 5 0 1179
Subject
Responsible
Party
Discussion
Action Due Date
(Assigned To)
December 21, 2016 Page 3
Pharmacy 20 0 1 2054
Pharmacist 67 412 0 11299
Vaccination 35 4 0 4339
Pharmacy
Intern -
Graduates
4 0 0 48
Pharmacy
Intern -
Students
25 17 0 832
Pharmacy
Technician
109 262 5 9552
D. Compliance Y. Wu,
Compliance
Manager
1. Unit Updates
2. Monthly Statistics
Complaints & Investigations:
New Complaints - 33
Resolved (Including Carryover) – 43
Actions within Goal – 30/43
Final disciplinary actions taken – 12
Summary Actions Taken – 0
Average days to complete - 139
Inspections:
Total - 117
Subject
Responsible
Party
Discussion
Action Due Date
(Assigned To)
December 21, 2016 Page 4
Annual Inspections - 107
Opening Inspections - 9
Closing Inspections - 0
Relocation Inspections - 0
Board Special Investigation Inspections – 1
Division of Drug Control Closing Inspections – 3
E. Legislation &
Regulations
B. Logan,
Legislation and
Regulations
Manager
CVS Health Comments COMAR 10.34.04 Transfer and
Outsourcing of Prescriptions and Prescription Orders
MPhA.Comments
Issue Papers 2017 Legislative Session
http://mgaleg.maryland.gov/Pubs/legislegal/2017rs-Issue-
Papers.pdf
PC CVS Response Regulatory Response
PC MPhA Response Regulatory Review
response (2)
III. Committee
Reports
A. Practice
Committee
C. Rochester,
Chair
1. Question Board of Pharmacy Call Center Yuzon:
I agree with the part which says : "The reason the Board requires
attestation of training by the pharmacist is because the training for
the administration of immunizations is not identical to the training
for administration of many self-administered drugs. " . I think that
question from the call center is still getting from callers is what types of
training are acceptable if these individuals do not recall taking this
throughout their pharmacy school. I think that it would be a good idea to
bring this to the practice committee as was talked about earlier to get
clarification on where individuals can get the training.
I think that the regs are clear in that the "CPR" is required if they attest
"yes" to the administration of self administered drugs. If they are also a
vaccine certified pharmacist and hold a current CPR card, then this CPR
card would be sufficient to meet the CPR card requirement for both the
vaccine piece and the self-administration piece.
Call Center Staff:
1. The training for immunization or
vaccines is acceptable as this generally
includes training to administer
subcutaneous, intramuscular types of
injections. However, training may also be
derived from documented experience
teaching patients on self-
administration, continuing education
programs or from school. If a pharmacist
does not have the requisite training, then he
or she must obtain such training through
one of the above means in order to
administer self-administered drugs in
accordance with COMAR 10.34.39.
Subject
Responsible
Party
Discussion
Action Due Date
(Assigned To)
December 21, 2016 Page 5
Hi Yuzon. I really need to get some help with that new attestation
question again. We still seem to get people that are not clear on this
while they are filling out their application. Is there anything you can do
to get more clarity on this question? That way applicants can have
specific ideas on what is being asked. We know what to tell them, and
we've added an FAQ, but they still seem to be confused about the
application.
Here is a recent email sent to the board:
Hello, I was wondering how to fulfill the requirement of " proper
training on the
Administration of Self-Administered Drugs per COMAR 10.34.39" if I
am applying for reciprocity -- is there a course or exam that I need to
take? I have been a retail pharmacist for almost 3 years.
2. Question: Mediscripts Rx sample forms
3. Question: Bill Irvin CVs Health; CVS is continually looking for
ways to address the opioid crisis in America. We have worked with
manufacturers to create “GPS tracker” bottles that are filled with colored
water and have tops that are built to not open. These are deployed in the
event of a robbery and are currently utilized in several states. Our goal is
to expand the program to include promethazine in Maryland. Please see
the attached pictures. We are seeking your approval to place these
amongst the regular stock of medication. I’d be glad to find answers to
any questions you may have.
Sincerely,
Bill
IMG_2345 (1)
2. PC Response Medicsripts approval
3. PC Response CVS GPS tracker
Subject
Responsible
Party
Discussion
Action Due Date
(Assigned To)
December 21, 2016 Page 6
IMG_2346
IMG_2347
4. Question: Emily Heil: I have a question related to the board of
pharmacy that I was hoping you may know the answer to or could
provide me with the best contact at the board. I have spoken with
Cherokee and Frank Palumbo about the question in brief as well.
At the hospital we offer a penicillin skin testing service that is currently
performed by our ID physician fellows. I know of a few hospitals in
different states (including TN and GA), where pharmacists perform and
interpret the test under a collaborative practice agreement with
physicians. It seems to me that this would be allowable based on
Maryland regulations, but I am having trouble finding a clear answer
since it's not as cut and dry as ordering a vancomycin level or giving an
immunization.
The test itself is very straightforward - essentially like administering a
ppd TB screening test. Do you think that is something pharmacists could
potentially do in MD under a collaborative practice? This is mostly a
theoretical question at this point as our current model at UMMC is
working well, but as we expand to the system level I am trying to think
of ways to expand access to testing.
Thanks!
Emily
5. Question: William Kuchinsky: My Mom, a widow of a veteran with
full health benefits, is transitioning to long term care.
She had been receiving her prescriptions under Tri-Care for Life
administered by Express-Scripts for FREE (no cost) via mail.
Now, as a patient at a Maryland nursing home, she has out of pocket
expenses of over $1,100 for the past 5 months or so.
4. PC Response Emily Heil Penicillin
Skin Test
5. PC Response Wil Kuchinsky
Subject
Responsible
Party
Discussion
Action Due Date
(Assigned To)
December 21, 2016 Page 7
Have been told by the pharmacist that this is due to the "track & trace"
laws, and that I can not have her medications shipped directly from
Express-Scripts to the home's pharmacy unless they are bubble carded.
It does not seem right that a widow of a veterans should LOOSE
BENEFITS because she is now in long term care.
If this is the incorrect office to direct this inquiry/note please direct to the
correct authority.
Thank you.
http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSec
urity/DrugSupplyChainSecurityAct/
http://www.pharmacist.com/track-and-trace-your-pharmacy-compliance-
new-law
B. Licensing
Committee
D. Ashby,
Chair
1. Review of Pharmacist Applications:
a. M. Abhari - Applicant is attempting to reciprocate in
Maryland and is requesting a waiver of the MPJE so
that she may begin working as a “Clinical Pharmacist
Strategist”.
Licensing Committee’s recommendations: Deny
request.
b. R. Albano - Licensee is asking for refund of $50 fee
paid to Berlitz for taking the Oral Competency exam.
Was incorrectly informed by Board on this requirement
on a status letter dated October 4, 2016.
Licensing Committee’s recommendations: Approve
request. Issue a $50 credit for the first renewal.
c. Applicant # 108644 – Applicant request Board
approval to retake MPJE after failed attempts.
Subject
Responsible
Party
Discussion
Action Due Date
(Assigned To)
December 21, 2016 Page 8
Licensing Committee’s recommendations: Approve
request.
d. Applicant # 110230 – Applicant request Board
approval to retake MPJE and NAPLEX after failed
attempts.
Licensing Committee’s recommendations: No
recommendation, for Board decision.
e. Applicant # 109734 – Applicant request Board
approval to retake NAPLEX after failed attempts.
Licensing Committee’s recommendations: No
recommendation, for Board decision.
f. T. Patel – Applicant is requesting a waiver of FPGEC
in order to reciprocate. On May 29, 2003, applicant
graduated from a Canadian Pharmacy School
accredited by the Canadian Council for Accreditation
of Pharmacy Programs (CCAPP) and recognized by
ACPE through June 30, 2004.
Licensing Committee’s recommendations: Approve
waiver of FPGEC requirement.
g. S. Sillah – Applicant is attempting to reciprocate and is
requesting waiver of the examination.
Licensing Committee’s recommendations: May transfer
NAPLEX score, but must take MPJE.
2. Review of Pharmacy Intern Applications: NONE
3. Review of Pharmacy Technician Applications: NONE
Subject
Responsible
Party
Discussion
Action Due Date
(Assigned To)
December 21, 2016 Page 9
4. Review of Distributor Applications: NONE
5. Review of Pharmacy Applications:
a. Divvymed, LLC dba Divvydose ( IL) – Application
received 08/24/2016, owner (100%) of the pharmacy is
a Physician. A Letter was sent on 09/12/2016
informing the applicant of MD Pharmacy Act
prohibiting a MD licensed pharmacist from
“associat[ing] as a partner, cower, or employee of a
pharmacy that is owned wholly or substantially by an
authorized prescriber of group of authorized
prescribers”.
Applicant responded 11/08/2016 requesting that the
Board issue the pharmacy permit while ensuring that
the Owner/Physician will not provide any pharmacy
services to patients that utilize the pharmacy.
Licensing Committee’s recommendations: Deny
request.
b. Gwynn Oak Pharmacy (MD) – Permit holder
requesting a refund of the application fee for the
relocation of the pharmacy. Submitted relocation
application in Nov. 2015, however, on Jan. 8, 2016, the
permit was closed. Owner reapplied and was issued a
new permit on Oct. 20, 2016.
Licensing Committee’s recommendations: Deny refund
request.
c. Keystone Rx, LLC (PA) – Application received listed
one of its owners (a Physician) having a 49%
ownership of the pharmacy. Letters and
correspondences were sent to the applicant informing
them of MD Pharmacy Act prohibiting a MD licensed
pharmacist from “associat[ing] as a partner, cower, or
Subject
Responsible
Party
Discussion
Action Due Date
(Assigned To)
December 21, 2016 Page 10
employee of a pharmacy that is owned wholly or
substantially by an authorized prescriber of group of
authorized prescribers”.
Response received stating that the Physician is listed as
an investor without an active role in the pharmacy and
is a “passive investor” with 49% ownership.
Licensing Committee’s recommendations: Deny
request.
d. Smith’s Detection (MD) – Applicant applied for a
waiver permit so that it can to order nitroglycerin to
incorporate into their consumables that are used to
trace detection equipment. It is not a pharmacy.
Licensing Committee’s recommendations: Permit not
required under MD law.
6. Review of Pharmacy Technicians Training Programs:
NONE
7. New Business:
a. Mccreary-Yates (Giant District Manager) –
Requesting an additional 3 months extension of the 6
month training period for technician in training E.
Stewart, who started on 05/22/16. Unable to continue
the training from 08/07/16 to 10/31/16.
Licensing Committee’s recommendations: Approve the
3 months extension and refer to Disciplinary
committee.
b. NABP Moral Character Reference – For the NABP
reciprocity application, is it acceptable for the
Subject
Responsible
Party
Discussion
Action Due Date
(Assigned To)
December 21, 2016 Page 11
pharmacist completing the moral character reference be
a family member of the applicant?
Licensing Committee’s recommendations: Acceptable.
C. Public
Relations
Committee
B. Zagnit,
Chair
Public Relations Committee Update:
D. Disciplinary T. Robinson,
Chair
Disciplinary Committee Update
E. Emergency
Preparedness
Task Force
S. Roy, Chair Emergency Preparedness Task Force Update
IV. Other Business
& FYI
M. Gavgani,
President
V. Adjournment M. Gavgani,
President
The Public Meeting will be adjourned.
M. Gavgani will convene a Closed Public Session to conduct a
medical review of technician applications.
C. The Closed Public Session will adjourn. Immediately
thereafter, M. Gavgani will convene an Administrative Session
for purposes of discussing confidential disciplinary cases.
With the exception of cases requiring recusals, the Board
Subject
Responsible
Party
Discussion
Action Due Date
(Assigned To)
December 21, 2016 Page 12
members present at the Public Meeting continued to
participate in the Administrative Session.